Organization name

AUDIO TECHNOLOGIES SRL

SRN

IT-MF-000010733

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use
• Contains biological material of animal origin
• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Do not use past indicated date

Primary placement in Italy; available across 32 countries total.

Trade name

BRAXON FAST

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08057143540780

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

805714354FT0014R

Reference / catalog number

FBRX06M

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The ‘Collagen Matrices for Breast Surgery’ product family identifies implantable medical devices made of collagen that are acellular and resorbable (i.e. biointegrated and subsequently biodegraded over time), sterile and single-use, intended as surgical reinforcement to protect and/or replace soft tissue, in order to aid and support tissue regeneration and to reduce the incidence of pericapsular fibrosis in breast surgery. The medical devices consist of preformed, acellular membranes, in various sizes, non-pyrogenic and freeze-dried, made from collagen derived exclusively from porcine dermal tissue.

Additional information URL

https://www.audiotechnologies.net/qualityregulatory

Clinical sizes

• 381–550 MU12

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.